UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009790 |
|---|---|
| Receipt number | R000011456 |
| Scientific Title | Toyama antihypertensive therapy with Olmesartan in Post-Stroke patients (TOPS) study |
| Date of disclosure of the study information | 2013/01/20 |
| Last modified on | 2013/01/15 21:57:51 |
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Basic information
Public title
Toyama antihypertensive therapy with Olmesartan in Post-Stroke patients (TOPS) study
Acronym
Toyama antihypertensive therapy with Olmesartan in Post-Stroke patients (TOPS) study
Scientific Title
Toyama antihypertensive therapy with Olmesartan in Post-Stroke patients (TOPS) study
Scientific Title:Acronym
Toyama antihypertensive therapy with Olmesartan in Post-Stroke patients (TOPS) study
Region
| Japan |
Condition
Condition
Hypertension, Post-stroke
Classification by specialty
| Medicine in general | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study investigate the effects of antihypertensive therapy using the angiotensin II receptor blocker (ARB) olmesartan as basal agent in post stroke patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Evaluation at 12 week and 24 week after
1) Blood pressure self-measured at home (home BP) in the early morning and evening, Morning/Evening ratio
2) Blood pressure at hospital (hospital BP)
3) The achievement rate of target blood pressures (at hospital and home)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Participants will be treated with 20mg olmesartan tablet once in the morning for 24 weeks.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Hypertensive patients with post stroke state (except cardiogenic embolism and subarachnoid hemorrhage)
Outpatients
20 years old or older at the time of the informed consent
Key exclusion criteria
Myocardial infarction, cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage, unknown type of stroke within previous 6 months (TIA can be registerd)
Grade III hypertension (systolic BP>=180mmHg or diastolic BP>=110mmHg)
Percutaneous or surgical coronary intervention (PCI, CABG etc.), severe heart failure within 6 months
Percutaneous or surgical coronary intervention planned
Persistent or permanent atrial fibrillation
History of congenital heart disease, rheumatic heart disease, moderate or severe valvular heart disease
Unstable angina, severe arrhythmia
Pregnant, possible to pregnancy
Not appropriate to long term observation
Difficult to obtain consent because of minors or dementia etc.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoshi Kuroda |
Organization
University of Toyama
Division name
Department of Neurosurgery
Zip code
Address
2630 Sugitani, Toyama-shi, Toyama, Japan
TEL
076-434-7348
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoki Akioka |
Organization
University of Toyama
Division name
Department of Neurosurgery
Zip code
Address
2630 Sugitani, Toyama-shi, Toyama, Japan
TEL
076-434-7348
Homepage URL
akioka@med.u-toyama.ac.jp
Sponsor or person
Institute
University of Toyama
Institute
Department
Personal name
Funding Source
Organization
University of Toyama
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
富山大学附属病院（富山県）、あさひ総合病院（富山県）、糸魚川総合病院（新潟県）、かみいち総合病院（富山県）、黒部市民病院（富山県）、厚生連高岡病院（富山県）、厚生連滑川病院（富山県）、済生会高岡病院（富山県）、済生会富山病院（富山県）、高岡市民病院（富山県）、塚本脳神経外科（富山県）、砺波総合病院（富山県）、富山赤十字病院（富山県）、南砺市民病院（富山県）、八尾総合病院（富山県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 01 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2012 | Year | 10 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2014 | Year | 02 | Month | 12 | Day |
Date of closure to data entry
| 2014 | Year | 02 | Month | 28 | Day |
Date trial data considered complete
| 2014 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2014 | Year | 04 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 01 | Month | 16 | Day |
Last modified on
| 2013 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011456
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